Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012731
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DECASPRAY | DEXAMETHASONE | 0.04% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL;TOPICAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/29/1961 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/29/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/08/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/05/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/24/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/02/1979 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |